Description
Syneos Health is seeking a Principal Biostatistician to join their team. As a Principal Biostatistician, you will serve as a statistical department resource, mentor biostatisticians, and oversee training plans and materials for Biostatistics associates.
Responsibilities:
- Prepare Statistical Analysis Plans (SAPs) and collaborate with sponsors
- Develop and review statistical aspects of protocols, randomization schedules, and clinical study reports
- Review SAS annotated case report forms, database designs, and study documentation
- Create and review programming specifications for analysis datasets, tables, listings, and figures
- Direct activities of other biostatistics personnel and provide independent review of project work
- Implement company objectives and create alternative solutions to address business challenges
- Serve as biostatistics representative on project teams and interface with other departmental project team representatives
- Conduct verification and quality control of project deliverables
- Manage scheduling and time constraints across multiple projects
- Provide statistical programming support as needed
- Participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities
- Lead projects involving integrated analyses and attend regulatory agency meetings
- Provide input and review applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), and regulatory guidelines
- Maintain well-organized project documentation and verification/quality control documents and programs
- Display willingness to work with others and assist with projects and initiatives as necessary
- Support business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings
The successful candidate will have the opportunity to work with a leading biopharmaceutical solutions organization and contribute to the acceleration of customer success.